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On Tech Ethics with CITI Program
Discusses a broad range of technology ethics topics. Hosted by Daniel Smith, Associate Director of Content and Education at CITI Program. New episodes every month. Learn more at about.citiprogram.org.
On Tech Ethics with CITI Program
AI and Software in Research: When FDA Rules Apply - On Tech Ethics
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CITI Program
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Season 1
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Episode 47
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Discusses regulatory considerations for research involving medical devices, particularly given the rise of AI and software as a medical device.
Our guest today is Lauren Hartsmith, who is a consultant at The HRP Consulting Group and a human subjects protection professional with over 15 years of experience in research compliance, Institutional Review Board oversight, and regulatory affairs.
Additional resources:
- FDA Software as a Medical Device: https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd
- FDA Clinical Decision Support Software Guidance: https://www.fda.gov/media/109618/download
- HRP Consulting Resources: https://thehrpconsultinggroup.com/resources/
- CITI Program’s Tech Ethics solution: https://about.citiprogram.org/solutions/tech-ethics/
Episode Introduction
Lauren Hartsmith’s Background in Research Compliance
When Software and AI Count as Medical Devices
Software as a Medical Device and the 21st Century Cures Act
Applying FDA Versus Common Rule Regulations
Human Data, Algorithm Development, and Early Regulatory Questions
Human Subjects Protections and Regulatory Exemptions
Mid-Episode Message About CITI Program’s On Research Podcast
IDE Requirements and Significant Risk Versus Non-Significant Risk Devices
How to Determine Whether 812 Applies
Documenting Device Study Determinations
Significant Risk Determinations in Context
Minimal Risk Versus Significant Risk Device Studies
Key Oversight Questions for IRBs and Researchers
Identifying What Is Actually Investigational
Companion Diagnostics and Interstate Commerce Considerations
Recommended Resources for Device Study Oversight
Episode Closing and Tech Ethics Training Promotion
